(This note is not part of the Regulations)
These Regulations, which extend to Scotland only, implement Commission Directive 2001/15/EC on substances that may be added for specific nutritional purposes in foods for particular nutritional uses.
These Regulations concern food for most particular nutritional uses (definition of “designated PNU food” in regulation 2(1) which excludes infant formulae, follow-on formulae, processed cereal-based foods and baby foods intended for infants and young children) where there has been added to that food for a specific nutritional purpose a substance falling within one of the following categories: vitamins; minerals; amino acids; carnitine and taurine; nucleotides, choline and inositol. The Regulations prohibit the sale of such food unless the substance is listed under the relevant category in Schedule 1 or, in the case of foods for special medical purposes, is listed under the relevant category in either Schedule 1 or 2. Relevant purity criteria must be met for the substance (regulation 3(1) to (3)).
The Regulations also impose general restrictions on the sale of designated PNU foods in the manufacture of which any substances have been used for specific nutritional purposes unless such food is safe and fulfils the particular nutritional requirements of the persons for whom it is intended (regulation 3(4)). The regulations require prior notification of the placing on the market for the first time of certain designated PNU foods to which L-tryptophan has been added for a specific nutritional purpose (notifiable food is defined in regulation 2(1)), and prohibit the sale of such foods where the notification requirement has not been met (regulation 4(1)) in order to enable the Food Standards Agency to verify that the requirements of regulation 3(4) are met. The Regulations also require the manufacturer or importer in the case of all other designated PNU foods to supply the Food Standards Agency with information if the Agency so requests to verify that those requirements of regulation 3(4) are met (regulation 4(3)).
The Regulations make provision as to responsibilities for enforcement (regulation 5); create offences and penalties (regulation 6) and apply certain provisions of the Food Safety Act 1990 (regulation 8). The Regulations provide a defence in relation to exports, in accordance with Articles 2 and 3 of Council Directive 89/397/EEC (O.J. No. L 186, 30.6.89, p.23) on the official control of foodstuffs (regulation 7).
The Regulations also disapply the prohibitions in the Tryptophan in Food (Scotland) Regulations 1990 in so far as they conflict with Directive 2001/15/EC, Article 5 of Commission Directive 91/321/EEC (O.J. No. L 175, 4.7.91, p.35) on infant formulae and follow-on formulae and Article 5 of Commission Directive 96/5/EC (O.J. No. L 49, 28.2.96, p.17) on processed cereal-based foods and baby foods for infants and young children.
A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect which these Regulations would have on business costs has been prepared and has been placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Labelling and Standards Division of the Food Standards Agency, 6th Floor, St Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.